MAUDE Adverse Event Report: PENUMBRA, INC. NEURON MAX 6F 088 LONG SHEATH; DQY

Catalog Number	PNML6F088804M
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2018-01778; 3005168196-2018-01779.
Event or Problem Description
During preparation for a medical procedure, the hospital staff found that each tip of three neuron max 6f 088 long sheath (neuron maxs'') was broken upon removal from the packaging.The damage to the neuron maxs'' was found prior to use.Therefore, the neuron maxs'' were not used during the procedure.The procedure was completed using a new neuron max.
Additional Manufacturer Narrative
Results: all of the returned neuron maxs were damaged at the distal tip.The packaging mandrels were loose from the packaging tape.Conclusions: evaluation of the returned neuron maxs revealed that the catheters were damaged at the tip.If the packaging mandrel becomes unsecured from the packaging tape it may become retracted into the packaging tube while attempting to remove the device.This may cause the tip of the neuron max to become pinned between the mandrel and packaging tube.If the catheter is subsequently retracted while pinned, the distal tip may become damaged.Those damages are likely a result of trying to forcefully remove the catheters from its packaging card.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report numbers: 3005168196-2018-01778 and 3005168196-2018-01779.

• Brand Name: NEURON MAX 6F 088 LONG SHEATH
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7864864
• Report Number: 3005168196-2018-01777
• Device Sequence Number: 11154769
• Product Code: DQY
• UDI-Device Identifier: 00814548012209
• UDI-Public: 00814548012209
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K111380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2018
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/29/2021
• Device Catalogue Number: PNML6F088804M
• Device Lot Number: F81672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/13/2018
• Supplement Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005